Analysis of AdCom Briefing Docs Released Oct 16, 2013

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Yesterday the FDA Briefing Documents from the Endocrinologic and Metabolic Drugs Advisory Committee Meeting were released to the public. You can view the entire 115-page pdf here. The only TWO questions the FDA has for the advisory panel are: 1) Discuss the efficacy results from the ANCHOR trial and will it translate into a meaningful … Continue reading

Does Vascepa Increase the Risk of Prostate Cancer?

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Today, the recent Theodore Brasky article published in major newspapers state that the intake of Omega-3 Fatty Acids increases the risk of prostate cancer by 71%. So does taking Vascepa increase your risk of getting prostate cancer? No! Because the Brasky study noted that the increased cancer risk was shown in subjects who were taking … Continue reading

FDA accepts Supplemental New Drug Application (sNDA) for Vascepa for the Treatment of Patients With High Triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia

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Big news hit the wires today for Amarin Corp. as the FDA has just accepted their Supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and < 500 … Continue reading

Is Amarin Going-It-Alone ?

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Amarin announced today that it has obtained $100 Million non-equity financing and will be hiring a sales force to help commercially launch Vascepa for its initial indication, the MARINE indication, in the early part of 1Q2013 while continuing to assess strategic alternatives. So does this mean Amarin is going-it-alone (GIA), or is this just Amarin … Continue reading

Plethora of AMRN downgrades in October 2012

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Ever since the unfortunate FDA delay on NCE status for Vascepa announced by management this week (its 3rd consecutive delay now), Amarin has been spooking Wall Street analysts. Is Amarin forced to go it alone now on the Vascepa Launch in 1Q2013? Or will big pharma continue to watch it from afar like a cheetah … Continue reading

Pfizer to Buyout Amarin / Vascepa!

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Many rumors here and there about who will eventually buyout Amarin because of its immensely lucrative Vascepa heart drug. But recent activities conclude me to say confidently that Pfizer will be the ultimate acquirer of Amarin. Here is why: Amarin patent 12/888994 had a recent update on September 10, 2012 to its application. This patent … Continue reading

Vascepa NCE decision delayed till October 12, 2012

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Amarin Corp. just announced today that the FDA has not made a decision yet on whether or not to grant Vascepa NCE (New Chemical Entity) status in the Orange Book August monthly supplement (the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations that details drug patents) which will be published on or around September 14th. … Continue reading

Vascepa being eyed by Big Pharma?

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With Vascepa having the potential to be next Lipitor in terms of lifetime sales, it doesn’t take a rocket scientist to come up with the simple and logical idea that Vascepa will probably be scooped up by Big Pharma (AstraZeneca, Pfizer, Merck, Abbott, GlaxoSmithKline, Bristol-Myers Squib, etc). The billion dollar question is when and by … Continue reading

VASCEPA vs. LOVAZA – Which Is Better?

VASCEPA vs. LOVAZA – Which is better and what are the benefits? Lovaza (omega-3-acid ethyl esters) Capsules are manufactured by GlaxoSmithKline and Lovaza is also a FDA-approved drug. It is a combination of ethyl esters of omega-3 fatty acids, primarily EPA and DHA, indicated as an adjunct to diet to reduce triglyceride levels in adult … Continue reading